Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. ...more
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more
Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more
180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Apotex Inc. et al. 0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida. •...more